The long-acting beta2 agonist (LABA) came out significantly better than placebo for forced expiratory volume over 1 second (FEV1) by all measures over the course of a day in both identical studies, Gregory Feldman, MD, of South Carolina Pharmaceutical Research in Spartanburg, and colleagues found.

Results for the once-daily drug were similar to those for the twice-daily LABA formoterol (Foradil Aerolizer) over the first 12 hours and over the entire 24-hour period but significantly poorer at 12 to 24 hours, the group reported here at the CHEST meeting.

A second report from the pooled 6-week trial results showed positive results on exercise capacity with olodaterol as well.

These findings followed similar positive results from a pair of 48-week studies in the phase III program for olodaterol in COPD.

The drug got a near-unanimous thumbs up from an FDA advisory panel in January for that indication. Although the agency typically follows such recommendations, it denied approval in March, citing manufacturing issues.

With so many bronchodilators already available in the clinic, there's a high bar for any new single agent, Rick Watson, MD, a pulmonologist in private practice in Findlay, Ohio, told MedPage Today.

The trend is more toward fixed-dose combinations to improve adherence, he noted in an interview.

But a once-daily LABA could have a niche to streamline the regimen for patients who don't need a twice-daily inhaled corticosteroid and are on once-daily tiotropium (Spiriva), Watson suggested.

"Compliance is always an issue," he said. "Anytime you start asking people to do something more than once a day you decrease compliance."

The two olodaterol 6-week trials compared the drug at 5 and 10 mcg once daily given via the Respimat inhaler compared against placebo and twice-daily formoterol at 12 mcg via the Aerolizer inhaler.

The trials included patients (99 in the one trial and 100 in the other) with moderate-to-severe COPD, either never-smokers or those who had quit more than a year before.

For one of the primary endpoints, FEV1 over the first 12 hours averaged 0.148 L better than placebo in one study and 0.172 L better in the other, with the lower 5 mcg olodaterol dose that the company sought approval for and a similar 0.148 and 0.174 L better than placebo at the 10 mcg dose (all P<0.0001).

By comparison, formoterol was 0.141 and 0.158 L better than placebo (both P<0.0001).

Results were similar for secondary endpoints FEV1 area under the curve in the first 3 hours and over 24 hours as well as at trough.

The comparison between olodaterol doses turned up no significant differences.

The 5-mcg olodaterol dose was statistically similar to formoterol for 12- and 24-hour FEV1 but 0.050 L lower over hours 12 to 24, when the formoterol patients had their second dose (P=0.0001).

In a second presentation, François Maltais, MD, of Université Laval in Quebec, reported that the 5-mcg olodaterol group was able to exercise 14% longer than with placebo in one trial (P≤0.0003), as measured by log-transformed endurance time until symptoms limited them, and 11% longer in the other (P≤0.002).

Overall adverse events were fairly similar between olodaterol and placebo, although cough came in at 3.2% with the 5-mcg dose and 2.2% on formoterol compared with 0.5% with placebo.

Bronchitis occurred in 3.7% of 5-mcg olodaterol-treated patients and 2.2% of formoterol-treated patients compared with 1.6% on placebo.

No new safety concerns emerged in the trials.

The trials were funded by Boehringer Ingelheim, with editorial assistance from Complete HealthVizion.

Feldman reported being primary investigator at South Carolina Pharmaceutical Research but having no other conflicts of interest to disclose.

Some of Feldman's co-authors were employees of Boehringer Ingelheim.

Maltais reported having consulting, speakers bureau, advisory committee, and such relationships with AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline as well as receiving grant funds from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Nycomed, and Pfizer.

Reviewed by Zalman S. Agus, MD Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner

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